Abstract
Objectives To determine the efficacy of widely available subtype clinical tests to characterize evaporative dry eye disease (EDED) related to meibomian gland dysfunction (MGD) compared to normal and to validate those clinical cut points in an independent sample. Methods A diagnostic accuracy study (52 subjects), an investigator-masked study, was followed by a larger independent sample (364 subjects) analysis to confirm efficacy in normal and EDED subjects. All subjects were 18 years of age and older and were classified using a battery of clinical tests for dry eye that included symptoms, tear meniscus height, tear stability, ocular staining, evaporative-specific tests, and the Schirmer I test. Results Normal (nondry eye; n = 26) and EDED (n = 26) subjects completed the efficacy study. The global tests of tear breakup time, staining, and symptoms all produced AUCs ≥ 0.70, representing acceptable discrimination. EDED-specific tests of eyelid marginal signs, gland secretion quality, and gland loss did not demonstrate acceptable test efficacy or differences between normal and EDED subjects. In a larger, independent sample of normal and EDED subjects, gland secretion quality and eyelid marginal score achieved acceptable diagnostic levels: AUCs of 0.789 (CI: 0.734–0.844) and 0.729 (CI: 0.648–0.810), respectively, but not lipid interferometry grade or lower eyelid gland dropout estimated using meiboscopy. Conclusions Meibomian gland secretion quality is an efficient and useful functional indicator in EDED and should be incorporated into core outcome sets for this dry eye subtype.
Highlights
Dry eye disease (DED) is a common clinical condition, affecting 5 to 50% of the population, depending on the sampling approach and diagnostic criteria [1]
No statistical difference was found for age in the three groups (ANOVA, p 0.184). e ADDE subject data were eliminated from the data set so that only normal and evaporative dry eye disease (EDED) subjects were compared
area under the curve (AUC), cut points, sensitivity, and specificity values were derived from receiver operating characteristic (ROC) analysis (Table 1). e index measure, summed meibomian gland dysfunction (MGD) score, attained 0.81 sensitivity, but only 0.46 specificity and an AUC of 0.578, slightly better than chance [18]. e summed MGD score did not differentiate normal from EDED subjects (p 0.960). e global dry eye tests of symptom questionnaires, tear breakup time (TBUT), and staining scores achieved test sensitivities near or above 0.70, considered an acceptable level for an effective dry eye test [6], as opposed to the EDED-specific tests for a general clinic that did not achieve an acceptable level of discrimination
Summary
Dry eye disease (DED) is a common clinical condition, affecting 5 to 50% of the population, depending on the sampling approach and diagnostic criteria [1]. Of all the dry eye diseases, evaporative dry eye disease (EDED) related to meibomian gland dysfunction (MGD) appears to be the more prevalent subtype [2]. As a common subtype of dry eye, EDED is a condition with major health and quality of life impacts that requires diagnostic methods that can monitor treatment. E parameters that comprise the COSs must be efficacious in diagnosing the medical condition and quantitative to establish the severity of the condition and to monitor the response to treatment. Despite several consensus recommendations to diagnose EDED, [2, 6] tests have not been globally adopted that might comprise a COS battery for EDED related to MGD
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